Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

May 25, 2021 updated by: Shire

A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
759

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda General Hospital
      • Kortrijk, Belgium, 8500
        • Vzw Az Groeninge
      • Roeselare, Belgium, 8800
        • Heilig Hart ziekenhuis vzw Roeselare-Menen
  • Canada
      • Quebec, Canada, G1S 4L8
        • CHAUQ- Hopital du Saint-Sacrement
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • Toronto, Ontario, Canada, M3N 2V7
        • Toronto Digestive Disease Associates, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Quebec City, Quebec, Canada, G2B 5S1
        • Alpha Recherche Clinique
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Hospital Pablo Tobon Uribe
      • Medellin, Antioquia, Colombia
        • Promotora Medica Las Americas S.A.
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Ugasend S.A.
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • FOQUS, Centro de Investigacion Clinica
  • Czechia
      • Ceske Budejovice, Czechia, 37001
        • Private Gastroenterology Centre
      • Ceske Budejovice, Czechia, 390 01
        • Derma Plus s.r.o. Gastroenterology
      • Hradec Kralove, Czechia, 50012
        • Hepato-Gastroenterology HK s.r.o.
      • Jablonec nad Nisou, Czechia, 46660
        • Nemocnice Jablonec nad Nisou
      • Plzen, Czechia, 30460
        • Faculty hospital Plzen- Lochotin
      • Prague, Czechia, 14021
        • IKEM (Institute klinicke a experimentalni mediciny)
      • Prague 7, Czechia, 17004
        • Klinicke Centrum ISCARE I.V.F.
      • Tabor, Czechia, 39003
        • Nemocnice Tábor a.s.
      • Usti nad Labem, Czechia, 40113
        • Massarykova Nemocnice-Masaryk Hospital
      • Usti nad Orlici, Czechia, 56218
        • Orlickoustecka nemocnice a.s. (Hospital)
  • France
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Nantes, France, 44000
        • CHU Nantes- Hôtel Dieu
  • Germany
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie
      • Lueneburg, Germany, 21339
        • Stawdtisches Klinikum Lueneburg Gastroenterologie
  • Hungary
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika
      • Gyula, Hungary, 5700
        • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
      • Miskolc, Hungary, H-3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat
      • Mosonmagyarovar, Hungary, 9200
        • Karolina Korhaz, Belgyogyaszat es Gasztroenterologia
      • Vac, Hungary, H-2600
        • Javorszky Odon Varosi Korhaz, Gasztroenterologia
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Asian Institute Of Gastroenterology
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • Manikya Institute of Gastroenterology & Hepatology
    • Assam
      • Guwahati, Assam, India, 781006
        • Institute of Digestive & Liver Diseases
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Mehta Hospital
    • Kamataka
      • Mangalore, Kamataka, India, 575001
        • Kasturba Medical College Hospital
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695607
        • Sree Gokulam Medical College and Research Foundation
    • Maharashtra
      • Nagpur, Maharashtra, India, 440 012
        • Gastroenterology & Endoscopy Centre
      • Pune, Maharashtra, India, 411004
        • Sahyandri Speciality Hospital
      • Pune, Maharashtra, India, 411030
        • Poona Hospital & Research Centre
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • S R Kalla Memorial Gastro & General Hospital
      • Jaipur, Rajasthan, India, 302017
        • Dr. Nijhawan Clinic
    • UP
      • Lucknow, UP, India, 226003
        • Chhatrapati Shahuji Maharaj Medical University
  • Ireland
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, 24
        • Adelaide and Meath Hospital
      • Dublin, Ireland, 4
        • St Vincents' University Hospital
  • Poland
      • Lodz, Poland, 90-302
        • NZOZ Centrum Medyczne Szpital Sw. Rodziny
      • Poznan, Poland, 61-485
        • NZOZ Centrum Medyczne HCP
      • Sopot, Poland, 81-756
        • Endoskopia Sp z o.o.
      • Torun, Poland, 80-100
        • Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii
      • Warszawa, Poland, 03-580
        • NZOZ Vivamed
      • Wroclaw, Poland, 50-023
        • LexMedica
      • Wroclaw, Poland, 54-144
        • EMC Instytut Medyczny SA
  • Romania
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 020475
        • Clinical Hospital "Dr. I. Cantacuzino"
      • Bucharest, Romania, 050098
        • Emergency University Clinical Hospital Bucuresti
      • Timisoara, Romania, 300002
        • Policlinic Algomed SRL
      • Timisoara, Romania, 300593
        • Policlinica "Dr. Citu" SRL
    • Mures
      • Targu Mures, Mures, Romania, 540461
        • CMI de Gastroenterologie
  • South Africa
      • Port Elizabeth, South Africa, 6057
        • Greenacres Hospital
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Rose Park Hospital Boanerges CC Trials
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4091
        • Parklands Medical Centre
    • KwaZulu- Natal
      • Durban, KwaZulu- Natal, South Africa, 4001
        • St. Augustine's Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7708
        • Kingsbury Hospital
      • Cape Town, Western Cape, South Africa, 7500
        • Panorama Medi-Clinic
      • Cape Town, Western Cape, South Africa, 7530
        • Louis Leipoldt Medical Centre
  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
  • United Kingdom
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • St Mark's Hospital
    • Oxfordshire
      • Headington, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates, PC
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Garden Grove, California, United States, 92840
        • Digestive & Liver Disease Specialists
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Conneticut Gastroenterolgy Institute
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • New Smyrna Beach, Florida, United States, 32168
        • United Medical Research
      • Palm Harbor, Florida, United States, 34684
        • Advances Gastroenterology Associates
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates, LLC
      • Marietta, Georgia, United States, 30067
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Moline, Illinois, United States, 61265
        • Midwest Clinical Research Associates
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Gastrointestinal Clinic of Quad Cities
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
      • Shreveport, Louisiana, United States, 71103
        • Louisiana Research Center, LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Digestive Disorders Associates
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates
    • Michigan
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive & Liver Disease, Inc.
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • Setauket, New York, United States, 11733
        • Gastrointestinal Research Associates
    • North Carolina
      • Greensboro, North Carolina, United States, 27402
        • LeBauer Research Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Ohio Gastroenterolgy and Liver Intstitute
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterology Associates of Lancaster, Ltd.
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Gastroenterology Associates, LLC
    • Texas
      • Houston, Texas, United States, 77090
        • S.D. Khan
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Clinic of San Antonio, PA
    • Utah
      • Sandy, Utah, United States, 84070
        • Colon and Rectal Disease Center
      • Sandy, Utah, United States, 84094
        • Physicians Research Option, LLC
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Alexandria Clinical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advances Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults aged 18 or older
  2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol
  3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)
  4. Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.

Exclusion Criteria:

  1. Severe UC
  2. Acute flare with onset greater than >6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated.
  3. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)
  4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2 g/day
  5. Acute flare on a 5-ASA maintenance therapy of >3.2 g/day
  6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening
  7. History of biologic (anti-TNF agent) use
  8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted
  9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MMX mesalamine/ mesalazine
Drug: MMX mesalamine/ mesalazine
4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
Other Names:
  • Lialda
  • Mezavant
  • Mezavant XL
  • Mezavant LP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase
Time Frame: 12 months
Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase
Time Frame: 12 months
Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
12 months
Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase
Time Frame: 12 months
Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.
12 months
Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase
Time Frame: 12 months
Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
12 months
Improvement in Rectal Bleeding Score During the Acute Phase
Time Frame: 3 and 8 weeks
Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
3 and 8 weeks
Improvement in Stool Frequency Symptoms During the Acute Phase
Time Frame: 3 and 8 weeks
Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
3 and 8 weeks
Percentage of Subjects in Complete Remission at Week 8 of Acute Phase
Time Frame: 8 Weeks
Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
8 Weeks
Percentage of Subjects in Partial Remission at Week 8 of Acute Phase
Time Frame: 8 weeks
Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD476-409
  • 2009-017044-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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